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Animal health and the trade in aquatic animals within and to the European Union.

The creation of a single European market has significantly extended the scope of veterinary animal and public health legislation. This extension includes aquatic animals, and a comprehensive set of directives and decisions has been developed to ensure free circulation of aquaculture animals and their products, while guaranteeing a high level of animal health. At the same time, and in the same context, other directives have been adopted which organise checks on animals and products within and to the European Union (EU), as well as accompanying financial measures. Animal health legislation for the movement of aquaculture animals is also based on a number of principles, including the following: --the definition of important pathogens and their hosts --zoning (regionalisation)--the obligation for EU Member States to move animals only from areas or farms with high health status to and between areas and farms with equal or lower health status--the prescription of a testing regime to improve animal health status in zones or farms. In addition, disease control prescriptions have been established or are being considered for adoption. These include the establishment of national and EU reference laboratories, as well as the application of contingency plans and the measures to be taken in the event of a disease outbreak.

Animals↗

Marketing authorization of veterinary medicinal products in Poland.

Opening of the European Agency for the Evaluation of Medicinal Products (EMEA) in London (February 1, 1995) has begun harmonization of international requirements in veterinary drug legislation in the European Union (EU). The main objective of this paper is to introduce the principal rules of veterinary drug registration in Poland, a candidate to membership in the EU. In Poland the basic guideline governing quality, production, marketing, and inspection of medicinal products is "The Pharmaceutical Products, Medical Materials, Pharmacies, Wholesaler Outlets, and Pharmacy Inspection Act, dated October 10, 1991." The detailed rules are given in directives of the Minister of Health or the Minister of Agriculture in case of veterinary medicinal products. Since 1993 licensing of drugs in Poland has become a universal procedure for both human and veterinary products. The common Committee of Drug and Medical Materials Registration, which is under control of the Minister of Health and Social Welfare, ensures that the quality, safety (e.g., maximum residue limits and current FAO/WHO and EEC regulations for products used in food-producing animals are accepted), and efficacy are the criteria for the registration process. During 1994-1996 almost 300 veterinary products (more than 200 from the EU) received marketing authorizations in Poland. All these products were evaluated and registered on a similar basis to those in the European Union.

Animals↗

Legislation covering the licensing of veterinary medicines in the United Kingdom.

The procedures used in the United Kingdom governing the licensing of veterinary medicines based on an advisory committee procedure are summarised. The article does not purport to cover all aspects of medicines legislation and must not be treated as a complete or authoritative statement of the law on any particular case. Reference should be made to the Medicines Act 1968 and regulations made under the Act. It does not cover EEC legislation.

Legislation, Drug↗